البلد: أرمينيا
اللغة: الإنجليزية
المصدر: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
clarithromycin
Hankook Korus Pharm Co.
J01FA09
clarithromycin
500mg
tablets
(10/1x10/) in blister and(100/10x10/) in blister
Prescription
Registered
2015-12-29
CLACIN-ASTERIA Tab. 500mg (Clarithromycin) To be prescribed ATC Code : J01FA09 CLACIN-ASTERIA Tab. 500mg 설명서(120*270) C-0 M-0 Y-0 K-100 [COMPOSITION] Each film coated tablet contains: Active ingredient Clarithromycin--------------------------------------------------------------------------------------------------------------------------- 500mg(potency) Excipients : Microcrystalline cellulose, Gelatinized starch, Povidone, Croscarmellose sodium, Colloidal Silicon Dioxide, Stearic Acid, Magnesium stearate, Talc, Hydroxypropyl methylcellulose 2910, Diacetylated Monoglycerides, Titanium oxide, Ethyl Vanillin, Sorbic acid, Yellow No. 5 [INDICATION] Lower respiratory tract Infection : Bronchitis, pneumonia Upper respiratory tract Infection : Pharryngitis, sinusitis Disseminates mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare H.pylori eradication to reduce the risk of duodenal ulcer recurrence [DOSAGE AND ADMINISTRATION] The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. _Children older than 12 years and adults:_ Standard dosage: The usual dose is 250 mg twice daily. High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. _Elimination of Helicobacter pylori in adults:_ In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin can be used in a dose of 500 mg twice daily during the eradication therapy in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily. _Dosage in renal functional impairment:_ The maximum recommended dosages should be reduced proportionately to renal impairment. At creatinine clearance rate of less than 30 ml/min, the dosage should be halved to 250 mg daily or in the most severe infections to 250 mg twice daily. The duration of treatment should not exceed 14 days in these patients. _Duration of therapy:_ The duration of therapy with Clarithromycin اقرأ الوثيقة كاملة
_Summary of Product Characteristics_ 1. NAME OF THE MEDICINAL PRODUCT Clacin-Asteria Tab. 500mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredient No. Chemical Name Quantity/Tab. Use 1 Clarithromycin 500.0mg Active (potency) ingredient Excipient(s) No. Chemical Name Quantity/Tab. Use 1 Microcrystalline cellulose 90.0mg Inactive 2 Gelatinized starch 75.0mg Inactive 3 Povidone 20.0mg Bonding agent 4 Croscarmellose sodium 40.0mg Disintegrant 5 Colloidal Silicon Dioxide 7.5mg Disintegrant 6 Stearic Acid 12.5mg Lubricant 7 Magnesium stearate 7.5mg Lubricant 8 Talc 17.5mg Lubricant 9 Hydroxypropyl 24.0mg Coating agent methylcellulose 2910 10 Diacetylated Monoglycerides 2.0mg Coating agent 11 Titanium oxide 4.0mg Coating agent 12 Ethyl Vanillin q.s flavoring agent 13 Sorbic acid 0.6mg Antioxidant 14 Yellow No. 5 q.s Coloring agent _Summary of Product Characteristics_ 3. PHARMACEUTICAL FORM Film coated Tablets 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Lower respiratory tract Infection : Bronchitis, pneumonia Upper respiratory tract Infection : Pharryngitis, sinusitis Disseminates mycobacterial infections due to Mycobacterium avium, or Mycobacterium intracellulare H.pylori eradication to reduce the risk of duodenal ulcer recurrence 4.2 Posology and method of administration The dosage of Clarithromycin film-coated Tablets depends on the clinical condition of the patient and has to be defined in any case by the physician. Children older than 12 years and adults: Standard dosage: The usual dose is 250 mg twice daily. High dosage treatment (severe infections): The usual dose may be increased to 500 mg twice daily in severe infections. Elimination of Helicobacter pylori in adults: In patients with gastro-duodenal ulcers due to H. pylori infection clarithromycin can be used in a dose of 500 mg twice daily during the eradication therapy in combination with amoxicillin 1000 mg twice daily and omeprazole 20 mg twice daily. Dosage in renal functional impairment: The maximum recommended dosages should be reduced اقرأ الوثيقة كاملة